Allogeneic haematopoietic stem cell transplantation from a matched donor in patients with chronic myeloid leukemia failing to gain normal hemopoiesis under TKIs therapy - NA

IVERSITà DEGLI STUDI MILANO BICOCCA0 sites20 target enrollmentMay 13, 2015

Overview

No summary available.

Registry

who.int

Start Date

May 13, 2015

End Date

TBD

Last Updated

5 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

IVERSITà DEGLI STUDI MILANO BICOCCA

•\-1\.Chronic Myeloid Leukaemia \-CML\- in chronic phase (CP)
•2\.Failure to achieve at least a Major Cytogenetic Response (MCyR) after a minimum of 18 months of TKIs treatment
•3\.Inability to tolerate 3 months of uninterrupted full dose TKIs therapy due to hematological toxicity
•4\.A minimum of three treatment interruptions due to hematological toxicity Availability of a HLA\-identical related donor (Matched Related Donor, MRD)
•5\.Availability of unrelated donor (Matched Unrelated Donor, MUD) satisfying the criteria of a 10/10 antigen match at HLA\-A, \-B, \-C and \- DRB1, \-DQB1 at high resolution typing, or 9/10 with a permissive – DP disparity according to Fleischhauer model (Crocchiolo et al, Blood 2009\)
•6\.Target graft size (bone marrow):
•7\.bone marrow: \> 3 x 106 CD34\+ cells/kg BW recipient
•or \> 3 x 108 nucleated cells/kg BW
•8\.Karnofsky Index \= 80 %
•9\.Age \=18 and \=70 years

•1\.Secondary malignancies
•2\.A hematopoietic cell transplantation\-specific comorbidity index (Sorror et al Appendix C) \> 4
•3\.Known and manifested malignant involvement of the CNS
•4\.Active infectious disease
•5\.Active HIV, HBV or HCV infection
•6\.Impaired liver function (Bilirubin \> upper normal limit; Transaminases \> 3\.0 x upper normal limit)
•7\.Impaired renal function (Creatinine\-clearance \< 60 ml/min; Serum Creatinine \> 1\.5 x upper normal limit).
•8\.Pleural effusion or ascites \> 1\.0 L
•9\.Pregnancy or lactation
•10\.Known hypersensitivity to Busilvex and/or fludarabine